Drugs: just say no. The hidden dangers

Blowing you own trumpet is briefly satisfying, like another solitary activity, but not very cool. However I’ve decided to succumb to the urge as its now six months since “10 Secrets of Health Ageing” was published and in a couple of weeks (Sunday 16th of November I’m going to be talking about it at the Blenheim Palace Literary Festival.

What’s been satisfying is that evidence keeps coming in to support arguments I and co-author Patrick Holford were first setting out 18 months ago. One of the central ones was that, despite the frequent claims that modern medicine is evidence based and firmly rooted in clinical trials, this is more of a hope than a reality.

If we are right this information is particularly important for baby boomers as they head into the medical badlands of 60+ where they are going to be encouraged to take an increasing number of drugs. If the evidence for their safety and effectiveness is actually much poorer than assumed, then becoming an informed consumer is very important. It also means that you’re not just being sensible giving various alternatives a try before accepting a prescription but you’d be daft not to.

So how have we done? This is what one researcher had to say after analysing the the evidence for the flu drug Tamiflu. “Meta-analyses of clinical trials are valuable to clinicians and health agencies for recommending treatment. But as several recent studies illustrate, they can be grossly limited and misleading.”

Relying on dodgy data

Meta-analyses are a way of combining results from a number of trials of a drug to get a more accurate picture of how well it performs. Tamiflu has been given to millions. The researcher here was working with the Cochrane Collaboration, an organisation dedicated to evidence based medicine.

Writing in the respected on-line magazine The-Scientist the researcher described how he was amazed at the mismatch that could occur between the information gathered in major clinical trials and the reports of those trials that appeared in the medical journals. Yet it’s those journal reports that scientists usually rely on to produce the meta-analyses that can ultimately determine what drugs you are offered.

But unreliable meta-analyses are just one of the crumbly bricks in the evidence based medicine wall. Another is failing to report or properly follow-up patients who dropped out of a trial. An analysis reported in June in the British Medical Journal, looked at 235 positive clinical trials over two years and found that failing to follow drop-outs up properly made a big difference to the results.

“We found that in up to a third of trials, the results that were reported as positive – in other words, statistically significant – would become negative – not statistically significant, if the investigators had appropriately taken into consideration those participants who were lost to follow-up.”

Damming conclusion

And it gets worse. Revelations that companies were hiding or simply not publishing unfavourable results – yet another factor distorting the evidence base supporting drug use – has meant that all companies have to post details of the trial they are planning to do on a website. This site now holds data on about 100,000 trials. These are the trials that are used to draw up the guidelines that doctors then use to decide which drugs to use to treat you and your family.

But when researchers analysed them to check for very basic things such as how many had enough people in them to produce accurate results, how many had a placebo control, how many were randomised, they came to a damming conclusion. Most of them were so poorly done that guidelines based on them couldn’t be considered reliable.

“Less than 15 per cent of major guideline recommendations,” wrote the authors in the Journal of the American Medical Association “are based on high-quality evidence.”

All of this is bad enough and certainly suggestions that caution about starting on a drug is essential, especially if it is a new one, and makes it vital to do some homework and ask lots of questions.

One very good place to get a far more comprehensive picture of the side-effects you are likely to encounter than shows up in the official literature is at a site called Rxisk.org. It’s run by the psychiatrist David Healy whose angry and informed critique of drug trials – “Pharmageddon” has recently been published.

We’ve become far more sceptical about the wisdom of allowing MPs, bankers, insurance companies and journalists to run their affairs without a strong and independent regulator. Yet pharmaceutical companies retain Teflon-like ability to shake off findings that would be fatal in other fields.

Until they lose that the onus is on you to put together your own package for health, which is what the “10 secrets of Healthy Ageing” provides. As well as advising drug awareness I’ll also be suggesting what else might work.

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